The RespoKare Anti-viral Child Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for…
The RespoKare Anti-viral Child Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The RespoKare Anti-viral Child Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%) that inactivate influenza viruses.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for RespoKare | Listed by | Innonix Technologies Limited, Hong Kong |
| FDA product code | OUK |
| Device type | Surgical Mask With Antimicrobial/Antiviral Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Record published | 2021-01-13 |
| Record revised | 2024-09-25 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-09-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.